Edgeone Medical
Delivering End-To-End Medical Device Services

Over the last five years, as the healthcare sector witnessed an accelerating drive toward value-based care and telehealth, emerging solution providers started developing tech-driven medical devices to support practitioners in pursuit of the Triple Aim: improving the experience, lowering costs, and improving outcomes. More recently, the COVID-19 pandemic accelerated this technical evolution, driving leading healthcare giants to design their medical devices and combination products for an increasingly digital world of healthcare. As a result, the medical devices industry is witnessing a surge in product design and safety regulations focused on connected health technology. This prompted a need for an end-to-end development and testing certification partner that can provide specialized services to assist the up-and-coming and prominent players in the medical devices space.

Illinois-based EdgeOne Medical addresses this gap through its services, resources, and facilities to support development at any stage in the product life cycle. Having been in the healthcare space for over 25 years now, Lilli Zakarija, co-founder and president of EdgeOne Medical observed the deficiency in the market, which included skill shortage and a lack of qualified external service providers that understood the interconnected relationship across development, design, testing and submission activities. With a mission to fill this void, she ventured into the medical device service provider industry.

Since its inception in 2012, EdgeOne has been delivering its comprehensive portfolio of product development services and ISO 13485 certified device testing labs to help biotech and MedTech firms realize innovative medical product development programs. In fact, today, EdgeOne Medical prides itself in being the trusted partner for more than seven of the top 20 global biopharma and medical device companies. “Our cross-functional product development experts work as an extension of client teams and ensure that the services we offer always satisfy the unique needs of our clients,” says Lilli.

The company’s development support services include testing services, which involves test method development and validation, design verification, and aging studies. Lilli emphasizes that the testing services they offer have been designed and validated around the client’s product with its specific requirements. The company understands the full spectrum of the product development lifecycle, whether it is developing a regulatory strategy, leading a device development program, or completing verification testing in a lab operating within an ISO 13485 certified quality system.

Further discussing the core competencies of her company, Lilli mentions how EdgeOne Medical’s ability to help its personnel safely remain onsite even while following the COVID safety guidelines enabled the company to help its customers maintain their project timelines, submission goals and more.

Our cross-functional product development experts work as an extension of client teams and ensure that the services we offer always satisfy the unique needs of our clients

According to Lilli, in 2020, companies were still figuring out how to work around the pandemic. As a result, firms today are driving a significant amount of resources and investment in holistically moving their projects forward. “This is driving an elevated demand across the market with respect to urgency, inquiries, specialized testing, and the overall momentum toward rapidly developing devices that accurately align with their specs and patient care goals,” explains Lilli.

As the market shifts toward connected devices and innovative tech-driven solutions, EdgeOne Medical aims to capitalize on the rising opportunity with its testing and product development services. The company not only facilitates timely testing of devices but also supports the overall development of a product with its expansive understanding of industry trends and technology know-how. “We translate our expertise directly to clients, which include larger organizations who are new to the medical devices arena, helping them traverse through unchartered waters with ease and efficiency,” adds Lilli. Another prime differentiator on EdgeOne Medical’s belt is its flexibility in aligning with client needs. For instance, during an ongoing product development project with a customer, the company was approached by the customer’s regulatory department to help them obtain a regulatory certification in a timely manner. With its expertise combined with operational flexibility, EdgeOne Medical was well poised to adapt to the customer’s internal operations and efficiently help them in holistically managing their product development and regulatory certifications.

With these unique capabilities, EdgeOne Medical assisted a plethora of clients over the last year—from top ten global biopharma to emerging venture-back health tech ventures. A significant cog in the company’s clockwork of success has been its new 20,000 sq. ft. facility, which enabled EdgeOne Medical to ensure operational continuum while complying with the internal and industry social distancing guidelines. Additionally, the company is currently expanding its laboratory space to better support pilot manufacturing for customers with niche requirements and developing newer capabilities to bridge the emerging gaps in the market.

Moving forward, EdgeOne Medical plans to grow its services portfolio to help additional firms adapt their technologies to the dynamic healthcare ecosystem. “We do not want to remain static throughout the market evolution and therefore, plan to continually enhance our skillsets and capabilities to support more companies develop their products,” concludes Lilli.